Apparatus to inject fluids into bone marrow and other target sites

ABSTRACT

The present disclosure relates to an apparatus for delivering a quantity of fluid to bone marrow. The apparatus may include a drive housing, a plunger operating assembly, a retractable sleeve, a first spring, a second spring, and a release mechanism. The drive housing may include a first portion configured to engage a driver assembly and a second portion configured to engage a cartridge assembly. The cartridge assembly may a fluid reservoir and a plunger assembly slidably disposed in the fluid reservoir. The cartridge assembly may be engaged with a bone penetrating needle and configured to rotate to insert the bone penetrating needle into the bone marrow. The first release mechanism may release the second spring to move the plunger operating assembly when the cartridge assembly is rotated to insert the bone penetrating needle into the bone marrow and the retractable sleeve is moved to a retracted position.

RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 12/718,638, filed Mar. 5, 2010, which is adivisional application of U.S. patent application Ser. No. 12/347,506,filed Dec. 31, 2008, now U.S. Pat. No. 8,038,664, which is a divisionalapplication of U.S. patent application Ser. No. 11/190,331, filed Jul.27, 2005, now U.S. Pat. No. 7,811,260, which is a continuation-in-partapplication of U.S. patent application Ser. No. 10/449,503, filed May30, 2003, now U.S. Pat. No. 7,670,328, which claims the benefit of U.S.Provisional Patent Application No. 60/384,756, filed May 31, 2002, thecontents of which are hereby incorporated in their entirety byreference.

TECHNICAL FIELD

The present disclosure is related to apparatus and methods for deliveryof fluids to a target site such as, but not limited to, bone marrow of abone and removal of fluids from a target site.

BACKGROUND

Every year, millions of patients are treated for life threateningemergencies in the United States. Such emergencies include shock,trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis,arrhythmias, bums, and status epilepticus just to name a few. Forexample, according to the American Heart Association, more than1,500,000 patients suffer from heart attacks (myocardial infarctions)every year, with over 500,000 of them dying from its devastatingcomplications.

An essential element for treating all such emergencies is the rapidestablishment of an intravenous (IV) line in order to administer drugsand fluids directly into the circulatory system. Whether in theambulance by paramedics, or in the emergency room by emergencyspecialists, the goal is the same—to start an IV in order to administerlife-saving drugs and fluids. To a large degree, the ability tosuccessfully treat such critical emergencies is dependent on the skilland luck of the operator in accomplishing vascular access. While it isrelatively easy to start an IV on some patients, doctors, nurses andparamedics often experience great difficulty establishing IV access inapproximately 20 percent of patients. These patients are probedrepeatedly with sharp needles in an attempt to solve this problem andmay require an invasive procedure to finally establish an intravenousroute.

A further complicating factor in achieving IV access occurs “in thefield” e.g. at the scene of an accident or during ambulance transportwhere it is difficult to see the target and excessive motion makeaccessing the venous system very difficult.

In the case of patients with chronic disease or the elderly, theavailability of easily-accessible veins may be depleted. Other patientsmay have no available IV sites due to anatomical scarcity of peripheralveins, obesity, extreme dehydration or previous IV drug use. For thesepatients, finding a suitable site for administering lifesaving drugsbecomes a monumental and frustrating task. While morbidity and mortalitystatistics are not generally available, it is known that many patientswith life-threatening emergencies have died of ensuing complicationsbecause access to the vascular system with life-saving IV therapy wasdelayed or simply not possible. For such patients, an alternativeapproach is required.

SUMMARY

In accordance with teachings of the present disclosure, an apparatusoperable to deliver a quantity of fluid to a target site such as bonemarrow of a bone may be provided. The apparatus may include a driver, aplunger operating and cartridge drive mechanism and a cartridge assemblyhaving a fluid reservoir with a bone penetrating needle coupled thereto.

In another embodiment an apparatus for delivering a quantity ofmedication to a target site may include a driver, a plunger operatingassembly or a plunger barrel having a first spring, a retractable sleevehaving a second spring and a fluid reservoir with a bone penetratorattached thereto.

In still another embodiment an apparatus for delivering a quantity offluid to bone marrow of a bone is provided that may include a powereddriver having a drill shaft operable for attachment with a plungeroperating and cartridge drive mechanism, a gear assembly operable toengage and rotate the drill shaft, a motor, a power supply andassociated circuitry operable to power the motor. The plunger operatingand cartridge drive mechanism may include a plunger operating assemblyand a retractable sleeve. A cartridge assembly having a fluid reservoiralong with a plunger assembly and a bone penetrating needle may bereleasably engaged with the plunger operating and cartridge drivemechanism.

In another embodiment a method for delivering a quantity of medicationto a target site such as, but not limited to, bone marrow of a bone maybe provided including compressing or cocking a portion of a plungeroperating and cartridge drive mechanism, inserting a fluid filledcartridge assembly into the cocked plunger operating and cartridge drivemechanism and penetrating into bone marrow until the plunger operatingand cartridge drive mechanism injects a quantity of fluid into the bonemarrow.

In a further embodiment a cartridge assembly operable to delivermedication to bone marrow of a bone may be provided with a detachablefluid reservoir, a plunger assembly, a bone penetrating needle andassociated fittings. The fluid reservoir may be formed at least in partfrom glass, glass composites, plastic or plastic composites.

For some embodiments, a bone penetrating needle may include a hollowlongitudinal bore with a closed tip at one end of the longitudinal bore.Side ports communicating with the longitudinal bore of the bonepenetrating needle may be angled to block or facilitate passage ofcertain substances.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A is a schematic drawing in elevation showing one example of anapparatus operable to deliver a quantity of medication to bone marrow;

FIG. 1B is an exploded, schematic drawing in section and in elevationwith portions broken away showing one example of an apparatus operableto deliver a quantity of medication to bone marrow in an unloaded,cocked position;

FIG. 1C is a schematic drawing in section with portions broken awayshowing one example of an apparatus operable to deliver a quantity ofmedication to bone marrow in a loaded position;

FIG. 1D is a schematic drawing in section with portions broken awayshowing one example of an apparatus operable to delivery a quantity ofmedication to bone marrow in a third, released position;

FIG. 1E is a schematic drawing in section and in elevation with portionsbroken away showing a bone penetrator communicating with bone marrow inaccordance with teachings of the present disclosure;

FIG. 1F is a schematic drawing showing an isometric view with portionsbroken away of one example of a pawl latch assembly satisfactory for usewith the apparatus of FIGS. 1B-1D;

FIG. 1G is a schematic drawing showing an isometric view with portionsbroken away of a pawl latch assembly holding a plunger operatingassembly or plunger barrel in a first, cocked position;

FIG. 1H is a schematic drawing showing an isometric view in section withportions broken away of the pawl latch assembly and plunger operatingassembly of FIG. 1G in a second, released position;

FIG. 1I is a schematic drawing in section taken along lines 1I-1I ofFIG. 1G;

FIG. 1J is a schematic drawing in section taken along lines 1J-1J ofFIG. 1H;

FIG. 2A is a schematic, exploded drawing in elevation showing oneexample of a cartridge assembly satisfactory for use with an apparatusoperable to deliver a quantity of medication to bone marrow;

FIG. 2B is a schematic drawing in elevation and in section showing thecartridge assembly of FIG. 2A;

FIG. 2C is a schematic, exploded drawing in elevation showing anotherexample of a cartridge assembly satisfactory for use with an apparatusoperable to deliver a quantity of medication to bone marrow;

FIG. 2D is a schematic drawing in elevation and in section showing thecartridge assembly of FIG. 2C;

FIG. 3A is a schematic drawing in elevation with portions broken awayshowing one example of a bone penetrating needle operable forcommunicating fluids with bone marrow;

FIG. 3B is a schematic drawing in elevation with portions broken awayshowing another example of a bone penetrating needle operable forcommunicating fluids with bone marrow;

FIG. 3C is a schematic drawing in section taken along lines 3C-3C ofFIG. 3A;

FIG. 4A is an exploded, schematic drawing in section and in elevationwith portions broken away showing one example of a cartridge assemblyreleasably engaged with a plunger operating and cartridge drivemechanism incorporating teachings of the present disclosure;

FIG. 4B is a schematic drawing in section and in elevation with portionsbroken away showing release of the cartridge assembly of FIG. 4A fromthe plunger operating and cartridge drive mechanism in accordance withteachings of the present disclosure;

FIG. 5 is a block diagram showing one method of delivering a quantity ofmedication to bone marrow;

FIG. 6 is a schematic drawing in section and in elevation showinganother example of an apparatus including a driver operable to deliver aquantity of medication to bone marrow;

FIG. 7A is a schematic drawing in section and in elevation with portionsbroken away showing another example of a cartridge assembly releasablyengaged with a plunger operating and cartridge drive mechanismincorporating accordance with teachings of the present disclosure;

FIG. 7B is a schematic drawing in section and in elevation with portionsbroken away showing release of the cartridge assembly of FIG. 7 A fromthe plunger operating and cartridge drive mechanism in accordance withteachings of the present disclosure;

FIG. 8A is a schematic drawing in section and in elevation with portionsbroken away showing still another example of a cartridge assemblyreleasably engaged with a plunger operating and cartridge drivemechanism incorporating teachings of the present disclosure; and

FIG. 8B is a schematic drawing in section and in elevation with portionsbroken away showing release of the cartridge assembly of FIG. 8A fromthe plunger operating and cartridge drive mechanism in accordance withteachings of the present disclosure.

DETAILED DESCRIPTION

Preferred embodiments of the disclosure and advantages are bestunderstood by reference to FIGS. 1A-8B wherein like numbers refer tosame and like parts.

The term “fluid” may be used within this patent application to includeany liquid or any mixture of liquids, particulate matter, dissolvedmedication and/or drugs appropriate for injection into bone marrow orother target sites. The term “fluid” may also be used within this patentapplication to include body fluids such as, but not limited to, bloodand cells which may be withdrawn from a target site.

The terms “fluid reservoir” and “reservoir” may be used in this patentapplication to include any chamber, cavity, ampoule, barrel, receptacleor any other device satisfactory for use with a cartridge assembly orother apparatus incorporating teachings of the present disclosure.

Examples of apparatus operable to access bone marrow and other targetsites in accordance with teachings of the present disclosure are showngenerally in FIGS. 1A-4B and 6-8B. One example of a method to accessbone marrow or other target sites in accordance with teachings of thepresent disclosure is shown generally in FIG. 5. However, the presentdisclosure is not limited to examples such as shown in FIGS. 1A-4B and6-8B or the method of delivering fluid to bone marrow as outlined inFIG. 5.

Various features of the present disclosure may be described with respectto apparatus 20 as shown in FIGS. 1A-1D and apparatus 220 as shown inFIG. 6. Apparatus 20 may have several positions such as an uncocked andunloaded position (not expressly shown), a cocked and unloaded positionsuch as shown in FIG. 1B, a cocked and loaded position such as shown inFIG. 1C and a discharged position after fluid has been injected from acartridge assembly at a target site such as shown in FIG. 1D.

Apparatus 20, as shown in FIGS. 1A-1D, may include housing 22 withdriver assembly 30 and plunger operating and cartridge drive mechanism50 disposed therein. Cartridge assembly 130 may be disposed withinportions of housing 22. See FIGS. 1B, 1C and 1D. Housing 22 may includehandle 24 which has been sized and contoured to fit the hand of anoperator (not expressly shown). Handle 24 may include on/off switch ortrigger 32. Housing 22 may also include receiver portion 26 having agenerally hollow, tubular configuration. First end or distal end 27 ofreceiver portion 26 may be open with portions of retractable sleeve 58slidably disposed therein. Second end or proximal end 28 of receiverportion 26 may be sealed or closed to protect various componentsassociated with driver assembly 30 and plunger operating and cartridgedrive mechanism 50.

Driver assembly 30 may include motor 34 connected to gearbox 36. Gearbox36 may be attached to drive shaft 38 to produce rotational motion ofplunger operating and cartridge drive mechanism 50. Various types ofmotors may be satisfactorily used to produce rotational, reciprocal orany other type of motion suitable to achieve results. In this exampleembodiment, motor 34 may be powered by battery pack 40. In alternativeembodiments, motor 34 may be powered by electricity from a standard walloutlet, an AC to DC converter solar power generator. A compressed orwound spring, gas cartridge or any other satisfactory power source foroperating a motor may also be used to operate apparatus 20.

Plunger operating and cartridge drive mechanism 50 may include firstspring 51, second spring 52 and third spring 53. See FIGS. 1B, 1C and1D. First spring 51 may sometimes be referred to as “plunger spring” 51.Second spring 52 may sometimes be referred to as “retractable sleevespring” 52. Third spring 53 may sometimes be referred to as “torsionalspring” or “pawl latch spring” 53. Various functions associated withsprings 51, 52 and 53 will be discussed later in more detail.

Plunger operating and cartridge drive mechanism 50 may also includerotatable housing 54, retractable sleeve 58, plunger operating assembly82, and pawl latch assembly 110. Retractable sleeve 58 may sometimes bereferred to as “spring loaded retractable sleeve 58.” Plunger operatingassembly 82 may sometimes be referred to as “spring loaded plungerbarrel 82.” Pawl latch assembly 110 may sometimes be referred to as“spring loaded pawl latch assembly 110.” Each of these components willbe discussed later in more detail.

Drive housing 54 may be used to transmit rotational forces or drillingforces from drive shaft 38 to a cartridge assembly releasably engagedwithin plunger operating and cartridge drive mechanism 50. The cartridgeassembly may include a fluid reservoir, a plunger assembly and a hollow,bone penetrating needle. Hollow, bone penetrating needles and hollowdrill bits incorporating teachings of the present disclosure maysometimes be referred to as “bone penetrators.” Rotational and/ordrilling forces from drive shaft 38 may be used to insert a bonepenetrating needle into bone marrow at a selected target site.

Examples of cartridge assemblies incorporating teachings of the presentdisclosure are shown in FIGS. 1B, 1D, 1C, 2A and 2B. However, a widevariety of other cartridge assemblies may be satisfactorily used with aplunger operating and cartridge drive mechanism incorporating teachingsof the present disclosure. The present disclosure is not limited tocartridge assemblies 130 and 130 a. The present disclosure is also notlimited to using only rotational and/or drilling forces to insert a bonepenetrating needle attached to a cartridge assembly at a selected targetsite. A plunger operating and cartridge drive mechanism incorporatingteachings of the present disclosure may also apply longitudinal or axialforce to a cartridge assembly to insert an attached bone penetratingneedle into bone marrow at a selected target site. Examples of driverswhich apply linear force (sometimes referred to as “impact drivers” or“impact driver devices”) are shown in U.S. patent application Ser. No.11/064,156 entitled “Impact-Driven Intraosseous Needle” filed Feb. 23,2005. Such drivers may be satisfactorily used with a cartridge assemblyincorporating teachings of the present disclosure.

Drive housing 54 may be described as having a hollow, generallycylindrical configuration defined in part by longitudinal bore 56.Plunger operating assembly 82 may be slidably disposed withinlongitudinal bore 56 which extends between first end 54 a and second end54 b of rotational housing 54. Portions of plunger operating assembly 82may extend from first end 54 a of rotational housing 54. See FIGS. 1B,1C, 1D and 1H. First end 54 a of rotational housing 54 may also beoperable to releasably engage a cartridge assembly incorporatingteachings of the present disclosure with plunger and drive mechanism 50.

Second end 54 b of drive housing 54 may be securely engaged with driveshaft 38. For embodiments such as shown in FIGS. 1B, 1C and 1D, coupling42 may be securely engaged with exterior portions of drive shaft 38 andinterior portions of rotational housing 54 proximate second end 54 b.Various types of mechanical fasteners such as set screws, pins, and/ordetents may be satisfactorily used to engage coupling 42 with driveshaft 38 and drive housing 54. Engagement between second end 54 b anddrive shaft 38 generally prevents longitudinal movement of drive housing54 relative to receiver portion 26 of housing 22.

The exterior dimensions and configurations of drive housing 54 may beselected to allow rotation of drive housing 54 with respect toretractable sleeve 58 and other components associated with plungeroperating and cartridge drive mechanism 50. Drive housing 54 may also berotatably disposed within various components associated with housing 22such as receiver portion 26 and interior support 23 b.

Plunger operating assembly 82 may be triggered or activated to applyforce to a plunger assembly associated with a cartridge assembly engagedwith first end 54 a of drive housing 54 to inject fluids from thecartridge assembly into bone marrow at a target site. Plunger operatingassembly 82 may have a first, retracted or cocked position such as shownin FIGS. 1B and 1G and a second, extended or released position such asshown in FIGS. 1D and 1H. Plunger operating assembly 82 preferablyincludes first end 82 a which may extend from first end 54 a of drivehousing 54. Second end 82 b of plunger operating assembly 82 may bedisposed adjacent to coupling 42 when plunger operating assembly 82 isin its first retracted or cocked position. See FIG. 1B. As discussedlater in more detail, pawl latch assembly 110 may be releasably engagedwith shoulder 88 to hold plunger operating assembly 82 in its first,retracted or cocked position. See FIGS. 1B and 1G.

Plunger operating assembly 82 may sometimes be described as a “plungerbarrel.” Plunger operating assembly 82 may have a generally cylindricalconfiguration defined in part by reduced outside diameter portion 84 andenlarged outside diameter portion 86. See FIGS. 1G and 1H. Shoulder 88may be formed on the exterior of plunger operating assembly 82 betweenreduced outside diameter portion 84 and enlarged inside diameter portion86. Reduced outside diameter portion 84 may include a generally hollow,cyndrical chamber or cavity 94.

A plunger rod or plunger shaft extending from an associated cartridgeassembly may be disposed within cavity 94. For example, FIGS. 1C and 1Dshow cartridge assembly 130 releasably engaged with first end 54 a ofdrive housing 54 and portions of plunger shaft 142 extending fromcartridge assembly 130 into cavity 94. During loading of apparatus 20,portions of plunger shaft 142 extending from cartridge assembly 130 orplunger shaft 142 a extending from cartridge assembly 130 a may beinserted into cavity 94.

Enlarged outside diameter portion 86 (FIG. 1B) may include generallyhollow, cylindrical chamber or cavity 96 with portions of first springor plunger spring 51 disposed therein. When plunger operating assembly82 is released from its first position by activation of pawl latchassembly 110, first spring 51 may provide sufficient force or energy topropel plunger shaft 142 and attach plunger or piston 144 into attachedcartridge assembly 130 to inject fluids from cartridge assembly 130 intobone marrow at a target site.

Plunger and drive mechanism 50 may also include retractable sleeve 58slidably disposed within housing 22. Sleeve 58 may be described as agenerally elongated, hollow cylinder defined in part by first end ordistal end 58 a and second end or proximal 58 b. Sleeve 58 may have afirst, extended position such as shown in FIGS. 1A, 1B and 1C and asecond, retracted position such as FIG. 1D.

As shown in FIGS. 1A-1D, cut-out or window 60 may be formed in sleeve 58proximate first end or distal end 58 a. Window 60 may be used to confirmthat a cartridge assembly has been loaded and properly seated intoapparatus 20. For some applications a retractable sleeve may be formedfrom clear, plastic-type material (not expressly shown) which would notrequire the use of cut-out or notch 60 to indicate when a cartridgeassembly has been releasably installed within apparatus 20.

As shown in FIGS. 1B-1D and 1G-1J, sleeve 58 may include reduced outsidediameter portion 64 and enlarged outside diameter portion 66 withshoulder 68 formed there between. Ramp or trigger 70 may be formed onthe inside diameter of sleeve 58 proximate shoulder 68. See FIGS. 1C, 1Iand 11. Ramp 70 may contact pawl latch assembly 110 while drive housing54 is rotating to release plunger operating assembly 82 when anassociated cartridge assembly has been inserted to a desired depth at atarget site. As shown in FIGS. 1D, 1I and 1J, longitudinal movement orsliding of sleeve 58 from first end 27 of housing 22 towards second end28 of housing 22 will result in ramp 70 contacting portions of pawllatch assembly 110 when drive housing 54 is rotating. Movement ofretractable sleeve 58 from its first extended position to a secondretracted position will generally not result in ramp 70 contacting orreleasing pawl latch assembly 110.

For some applications, receiver portion 26 of housing 22 may includefirst interior support 23 a and second interior support 23 b. See FIGS.1B, 1C and 1D. Interior supports 23 a and 23 b are preferably spacedfrom each other and securely engaged with receiver portion 26. For someapplications interior supports 23 a and 23 b may have a generallycircular opening formed therein (not expressly shown). The opening infirst interior support 23 a may be sized to slidably receive reducedoutside diameter portion 64 of sleeve 58. As shown in FIGS. 1B and 1Cinterior support 23 a may engage or contact shoulder 66 when sleeve 58is in its first, extended position.

Second interior support 23 b may have a generally circular openingformed therein (not expressly shown) and may be sized to be compatiblewith the outside diameter of drive housing 54. See FIGS. 1B-1D. Secondspring 52 maybe disposed within receiver portion 26 of housing 22between second support 23 b and a recess defined in part by shoulder 72formed on the interior of enlarged outside diameter portion 66 of sleeve58. Portions of drive housing 54 may be disposed within second spring52. See FIG. 1C.

When a bone penetrating needle of an associated cartridge assembly isinserted into bone marrow at a target site, sleeve 58 will generallyretract or slide from first end 27 of housing 22 towards second end 28of housing 27. See FIG. 1D. This movement will compress second spring 52between second support 23 b and shoulder 72 formed on the interior ofenlarged outside diameter portion 66. When apparatus 20 is removed fromcontact with a patient's skin, second spring 52 will return sleeve 58 toits first, extended position as shown in FIG. 1B with shoulder 68contacting first support 23 a.

Movement of retractable sleeve 58 from its first, extended position(FIGS. 1B and 1C) to its second, retracted position (FIG. 1D), as anassociated bone penetrating needle is inserted into bone marrow at atarget site, may result in pawl latch assembly 110 contacting ramp ortrigger 70 during rotation of drive housing 54. See FIGS. 1I and 1J.Ramp 70 will then move pawl latch assembly 110 from its first, blockingposition (FIGS. 1B and 1G) to its second position (FIGS. 1D and 1J)which results in release of plunger operating assembly 82 from itsfirst, cocked position such as shown in FIG. 1B. First spring 51 maythen move plunger operating assembly 82 to its second, released or firedposition such as shown in FIG. 1D. Pawl latch assembly 110 is only oneexample of a mechanism satisfactory for releasing a plunger operatingassembly from a cocked position.

FIG. 1E shows bone penetrator 160 inserted into bone 334 and associatedbone marrow 336. Bone 334 may be generally described as a humeral head.For some applications a humeral head may be a preferred target site dueto relatively high blood flow rates through associated bone marrow andrelatively easy access. Various types of connections may be used tocommunicate fluids with bone marrow 336 via bone penetrator 160 andintravenous tubing 340. For example right angle connector 342 may beengaged with one end of tubing 340. Right angle connector 342 has theadvantage of allowing tubing 340 to be connected to bone penetrator 160at an angle that will not kink or pinch off the lumen of tubing 340.Right angle connector 342 may also include Luer fitting 343 sized to beinserted into end 302 of hub 300. Locknut 344 may be used to engageright angle connector 342 with threaded connection 303 adjacent tosecond end 302 of hub 300.

Many medical devices such as syringes, hypodermic needles, catheters, IVtubing and stop cocks may include either a pin (male) or box (female)Luer type fitting. The pin end or box end may include threads whichallow releasably engaging an associated medical device with otherequipment having a complimentary Luer type fitting. Luer typeconnections may sometimes be described as Luer slips or Luer locks. Luerslips may require a half twist of an associated collar to securelyengage a pin end and a box end with each other. A Luer lock functions byforming a watertight fit between a pin and a box when engaged and whentwisted by a half turn or more. Luer looks frequently include a threadedlooking collar on a box end which mates with ears or projections from anassociated pin end to provide a more positive, locked connection. Luerconnections generally form fluid tight seals. Some Luer connections mayinclude tapered fittings.

For some applications second end 302 of hub 300 may be modified to haveone or more features of such previously described Luer connections.Second end 302 and threaded connection 303 of hub 300 may be designed toaccommodate attachment of various types of connectors used tocommunicate fluids with bone marrow or other target sites via bonepenetrator 160.

FIG. 1E illustrates only one example of a connector that may be used tocommunicate fluids between bone penetrator 160 and tubing 340.Intravenous tubing may be used to provide intravenous fluids and/ormedications to associated bone marrow. The tubing may also be used inwithdrawing a sample of blood from the bone marrow. Other connectors oradapters may also be used to connect a penetrator to intravenous tubing,other types of tubing and/or a syringe.

As shown in FIGS. 1B, 1C, 1D and 1F-1J pawl latch assembly 110 may bedisposed within portions of drive housing 54 intermediate first end 54 aand second end 54 b. Pawl latch assembly 110 may include pivot shaft 112with pawl or cam 114 rotatably mounted thereon. Pawl 114 may includefirst lobe 114 a and second lobe 114 b extending from pivot shaft 112.First lobe or first portion 114 a may be sized to releasably engageshoulder 88 formed on the exterior of plunger operating assembly 82.Second lobe or second portion 114 b may be sized to engage ramp ortrigger 70. Third spring or pawl spring 53 may also be mounted on pivotshaft 112 and engaged with pawl 114.

Pawl 114 may have a first position such as shown in FIGS. 1B and 1Gwhich corresponds with the first, cocked position of associated plungeroperating assembly 82. Third spring 53 preferably biases pawl 114 to itsfirst position which releasably engages first lobe 114 a with shoulder88. Pawl 114 may have a second position which corresponds with thesecond, released position for plunger operating assembly 82. See FIGS.1D and 1H.

For some applications drive housing 54 may include opening or channel116 extending from first end 54 a. Opening or channel 116 may be sizedto accommodate insertion of pivot pin 112 into associated pawl 114 andthird spring 53. See FIGS. 1G and 1H. Drive housing 54 may also includeopening or channel 118 sized to receive the opposite end of pivot shaft112. See FIGS. 1B and 1D. A window or notch maybe formed in the exteriorof drive housing 54 to allow inserting portions of pawl 114 includinglobe 114 b therethrough.

When plunger operating assembly 82 is in its first, cocked position,second lobe or second portion 114 b of pawl 114 will be spacedlongitudinally from ramp or trigger 70. During rotation of an associatedcartridge assembly and insertion of a bone penetrator at a target site,retractable sleeve 58 will slide longitudinally relative to the exteriorof drive housing 54. The longitudinal movement of retractable sleeve 58in combination with rotation of drive housing 54 will result in ramp ortrigger 70 engaging second lobe 114 b which rotates pawl 114 on pivotpin 112. Such rotation results in first lobe 114 a releasing or allowingplunger operating assembly 82 to move from its first, cocked position toits second, released position. As previously discussed, this movementmay result in injection of fluids from cartridge assembly 130 throughpenetrator 160 into bone marrow at a target site.

Cartridge assemblies formed in accordance with teachings of the presentdisclosure may include a fluid reservoir having a generally hollow,cylindrical configuration defined in part by a first, distal end and asecond, proximal end. A hub with a hollow, bone penetrating needle maybe attached to the first, distal end. Portions of a plunger assembly maybe slidably disposed within the fluid reservoir to force fluidscontained in the fluid reservoir through an attached hollow, bonepenetrating needle. The plunger assembly may include a plunger shaft andplunger piston. Portions of the plunger shaft may extend from thesecond, proximal end of the fluid reservoir.

For some applications, cartridge assemblies incorporating teachings ofthe present disclosure may be prefilled with a specific fluid usingtechniques associated with prefilled syringes. For other applications,cartridge assemblies incorporating teachings of the present disclosuremay normally be empty until filled with a fluid or medication prior touse of each cartridge assembly. Cartridge assemblies incorporatingteachings of the present disclosure will often be disposed of after asingle use. However, for some applications, cartridge assembliesincorporating teachings of the present disclosure may be used multipletimes and may be used at one or more target sites.

Cartridge assemblies and associated fluid reservoirs may have a widevariety of configurations and functions similar to a hypodermic syringe,an insulin syringe or a tuberculin syringe. For example, fluidreservoirs 132 and 132 a (FIGS. 2A and 2C) may contain a quantity offluid with medication or a drug for delivery to bone marrow or anotherselected target site. The medication or drug may often be available inliquid form. However, any suitable form of drug including solid, powder,capsule or any other known form may be used. Medication or drugs mayinclude, for example, emergency drugs for cardiac resuscitation,antibiotics, antidotes and any other drug suitable for administration toa body. Fluid reservoirs 132 and 132 a may also be used for injection ofintravenous fluids or any other substance desired for a specificpurpose.

Various features of the present disclosure may be described with respectto cartridge assemblies 130 and 130 a as shown in FIGS. 2A-2D. Cartridgeassemblies incorporating teachings of the present disclosure may havesome characteristics associated with medical syringes. However, variouscomponents associated with cartridge assemblies 130 and 130 a may bemodified in accordance with teachings of the present disclosure toaccommodate insertion of an associated hollow, bone penetrating needleinto bone marrow or other selected target sites.

Cartridge assembly 130 may include barrel or fluid reservoir 132 havinga generally hollow, cylindrical configuration defined in part by insidediameter 134. Barrel 132 may include first end 131 and second end 133.Hub 300 and associated hollow bone penetrating needle or bone penetrator160 may be releasably engaged with first end 131. Barrel 132 may beformed from reusable glass, disposable plastic, glass composite, plasticcomposites and any other material suitable to contain fluids dependingupon intended uses for cartridge assembly 130. Barrel 132 may sometimesbe described as an “ampoule.”

Various types of plunger assemblies may be satisfactorily used with acartridge assembly incorporating teachings of the present disclosure.For some applications plunger assembly 140 may include plunger shaft orplunger rod 142 and plunger piston 144. For some applications first end145 of plunger shaft 142 may be releasably engaged with plunger piston144. For other applications plunger shaft 142 may be securely engagedwith plunger piston 144. One or more projections 146 may be formed onthe outside diameter of plunger piston 144 to form a generally fluidtight, moveable seal with respect to inside diameter 134 of barrel 132.Plunger piston 144 may also function as a fluid seal or stopper tomaintain any fluids contained within fluid reservoir 132 prior toloading cartridge assembly 130 into apparatus 20 or 220. Various typesof elastomeric materials may be satisfactorily used to form plungerpiston 144.

Plunger assembly 140 may slidably move from second end 133 of barrel 132toward first end 131 in response to an axial force applied to plungershaft 142. Release of plunger operating assembly 82 from its first,retracted or cocked position (FIG. 1B) allows first spring or plungerspring 51 to apply an axial force or a longitudinal force to plungershaft 142 and move piston 144 from its first position adjacent to secondend 133 to a second position adjacent to first end 131 of fluidreservoir 132 (FIG. 1D). Such movement of piston 144 may result in fluidfrom barrel 132 being injected through bone penetrating needle 160 intobone marrow or another target site.

Piston 144 may include recess 148 sized to receive threaded connection303 formed adjacent to second end 302 of hub 300. Engagement of piston144 with the threaded connection 303 may allow disengagement ofreservoir 132 from hub 300. Drive connector 150 may be securely engagedwith second end 133 of barrel 132 opposite from hub 300 (FIGS. 2A and2B).

Drive connector 150 may have one or more recesses 152 formed therein andsized to receive corresponding segment 154 extending from first end 54 aof drive housing 54. See for example FIGS. 4A and 4B. The dimensions ofeach recess 152 may be selected to form a secure, snug fit withassociated segment 154. Rotation of drive housing 54 will result in eachsegment 154 contacting associated recess 152 to rotate drive connector150 and attached barrel 132. The connection formed between hub 300 andfirst end 131 of barrel 132 is preferably designed to allow transfer ofsuch rotation to attached bone penetrating needle 160.

As shown in FIGS. 2A and 2B, a plurality of magnets 138 may be disposedin drive connector 150 at locations which allow forming a releasablemagnetic engagement with first end 54 a of drive housing 54. Recesses152, segments 154 and magnets 138 cooperate with each other to allowreleasable engagement between cartridge assembly 130 and first end 54 aof drive housing 54.

As shown in FIGS. 1E, 2A and 2B, hub 300 may be used to stabilize anattached bone penetrator such as, but not limited to, bone penetratingneedle 160 during insertion into a patient's skin, soft tissue andadjacent bone or other target site. The combination of hub 300 with bonepenetrator 160 may sometimes be referred to as a penetrator set orintraosseous needle. First end 301 of hub 300 may have a size andconfiguration compatible with a selected target site for inserting bonepenetrator 160. Examples of such target sites include, but are notlimited to, a humeral head, a tibia, or a sternum. Second end 302 andthreaded connection 303 of hub 300 may be operable to be releasablyengaged with barrel 132. End 131 of barrel 132 may have a generallycircular opening sized to receive second end 302 of hub 300 therein.Optional O-ring 306 or any other suitable fluid seal may be disposed onexterior portions of hub 300 to form a fluid barrier between adjacentinterior portions of barrel 132. See FIGS. 2A and 2B.

Cartridge assembly 130 a as shown in FIGS. 2C and 2D may include barrelor fluid reservoir 132 a having a hollow, generally cylindricalconfiguration defined in part by inside diameter portions 134 a, 134 band 134 c. Barrel 132 a may include first end 131 a and second end 133.Hub 300 and associated bone penetrating needle 160 may be engaged withfirst end 131 a. Barrel 132 a may be formed from materials such as usedto form barrel 132.

Various types of plunger assemblies may be satisfactorily used withcartridge assembly 130 a. For some applications plunger assembly 140 amay include plunger shaft or plunger rod 142 a and plunger piston 144 a.For some applications, first end 145 of plunger shaft 142 a may besecurely engaged with plunger piston 144 a. For other applications,first end 145 may be releasably engaged with piston 144 a such as shownin FIGS. 2D, 4B, 7B and 8B.

One or more projections 146 may be formed on the outside diameter ofplunger piston 144 a to form a generally fluid tight, moveable seal withrespect to inside diameter portion 134 a. First end 147 of piston 144 amay be configured to form a generally fluid tight seal with taperedinterior surface 134 b of barrel 132 a. Plunger piston 144 a may alsofunction as a fluid seal or stopper to maintain fluids contained withinreservoir 132 a prior to inserting cartridge assembly 130 a intoapparatus 200 or 220. Various types of elastomeric materials may besatisfactorily used to form plunger piston 144 a.

Plunger assembly 140 a may slidably move from second end 133 of barrel132 a towards first end 131 a in response to an axial force applied toplunger shaft 142 a. Release of plunger operating assembly 82 from itsfirst, retracted position allows first spring or plunger spring 51 toapply an axial force or a longitudinal force to move piston 144 a fromits first position adjacent to second end 133 to a second position whichforms a generally fluid tight seal with tapered, inside diameter portion134 b of barrel 132 a.

As shown in FIGS. 2C and 2D, second end 302 of hub 300 a may also beengaged with barrel 132 a. End 131 a of barrel 132 a may include reducedinside diameter portion 134 c with threads 137 formed therein. Thedimensions of inside diameter portion 134 c may be selected to becompatible with the outside diameter of second end 302 of hub 300 a.Second end 302 of hub 300 a may include threads 303 or other suitablefitting formed on the exterior therein. Threads 303 may be engaged withthreads 137. Second end 302 may have a generally cylindrical pin typeconfiguration compatible with engaging first end or box end 131 a ofbarrel 132 a. For many applications hub 300 a will remain securelyengaged with first end 131 a of barrel 132 a during use of associatedcartridge assembly 130 a.

For some applications first end 301 of hub 300 a may have the generalconfiguration of a flange. Slot or groove 304 may be formed in first end301 and sized to receive one end of protective cover or needle cap 334.Slot or groove 304 may be used to releasably engage cover 334 with hub300 a.

As shown in FIGS. 2C and 2D, a plurality of ridges 320 may be formed onexterior portions of hub 300 a to allow an operator to grasp theassociated penetrator assembly or penetrator set while loading anassociated cartridge assembly into apparatus 20 or 220. Ridges 320 mayalso aid in removal of bone penetrator 160 from a target site.Longitudinal ridges 320 may also be grasped for engagement and/ordisengagement of hub 300 a with first end 131 a of barrel 132 a.

The dimensions and configuration of first end 301 of hub 300 a may bevaried to accommodate various target sites and/or patients. Hub 300 amay be satisfactorily used with a wide variety of flanges or otherconfigurations compatible with contacting a patient's skin. The presentdisclosure is not limited to hub 300 a or bone penetrator 160.

For some applications a cartridge assembly may include only a singlehollow bone penetrating needle. For other applications a cartridgeassembly may include an outer penetrator such as a cannula or hollowbone needle or hollow drill bit (not expressly shown) and an innerpenetrator such as a stylet, trocar or other removable device (notexpressly shown) disposed within the outer penetrator. For someembodiments bone penetrating needles 160 and 160 a may include a stylet(not expressly shown).

Penetrators may be relatively small for pediatric patients, medium-sizedfor adults and large for oversized adults. The length and diameter ofthe penetrator used in a particular application may depend upon the sizeof a bone to which the apparatus may be applied. Penetrators may beprovided in a wide variety of configurations depending upon intendedclinical purposes for insertion of the associated penetrator assembly.For example, there may be one configuration for administering drugs orfluids to a patient's bone marrow and an alternative configuration forsampling bone and/or blood from a patient. Other configurations may beappropriate for bone and/or tissue biopsy. Some penetrators may besuitable for more than one purpose. The configuration and size of a bonepenetrator may also vary depending upon the target site chosen forinsertion of each penetrator. The present disclosure is not limited tobone penetrators 160 or 160 a.

A wide variety of hollow bone penetrating needles and hollow drills maybe satisfactorily used to deliver a quantity of medication to bonemarrow or other target sites in accordance with teachings of the presentdisclosure. Hollow, bone penetrating needles 160 and 160 a as shownrespectively in FIGS. 3A and 3B are representative of only two examplesof bone penetrators that may be satisfactorily used with apparatus ofthe present disclosure. Bone penetrators 160 and 160 a are examples of asingle, hollow penetrator. The size of bone penetrators 160 and 160 amay vary depending upon a selected target site and/or intendedapplications for an associated cartridge assembly.

Bone penetrating needles 160 and 160 a may be formed of stainless steelor any other suitable material. Respective closed tips 162 suitable fordrilling through a bone into associated bone marrow, may be formed on arespective first end of bone penetrators 160 and 160 a. Closed tip 162may include at least one cutting edge 170 that enables efficientdrilling through bone to associated bone marrow with minimal trauma torespective outer bony cortex.

Outside diameter or exterior portion 168 of bone penetrators 160 and 160a may be selected to accommodate secure engagement with an associatedhub. A second end of each bone penetrator 160 and 160 a opposite fromrespective tip 170 may be sized to receive fluid from an attachedcartridge assembly.

Bone penetrators 160 and 160 a may include one or more side ports 164for release of medication or communication of fluid with adjacent bonemarrow. Side ports 164, holes in the side of bone penetrators 160 and160 a, may be configured to block passage of bone chips and debris intolongitudinal bore 166. By way of example and not limitation, one way toconfigure side ports 164 is to angle each side port 164 in a directionthat is opposite to the direction of drilling. Alternatively, bonepenetrating needle 160 and 160 a may include a sleeve expressly shown)that blocks passage of bony fragments into longitudinal bore 166 of bonepenetrator 160 or 160 a.

FIG. 3C is a schematic drawing in section showing side port 164 offsetor angled relative to longitudinal axis 169 of longitudinal bore 166.One or more side ports 164 may be formed at an acute angle relative toassociated longitudinal bore 166 and longitudinal axis 169 to minimizeobstruction or clogging of each side port 164 and associatedlongitudinal bore 166 by bone fragments (not expressly shown) and/orsoft body tissue (not expressly shown). For example if drilling occursin a clockwise direction, side ports 164 may be angled counterclockwise. See FIG. 3C.

FIGS. 4A and 4B show another mechanism satisfactory for releasablyengaging a cartridge assembly with portions of a plunger operating andcartridge drive mechanism in accordance with teachings of the presentdisclosure. However, a wide variety of releasable mechanisms other thanmagnets 138 such as shown in FIGS. 2A-2D or ball detent mechanisms suchas shown in FIGS. 4A and 4B or collet latch mechanisms such as shown inFIGS. 7A, 7B, 8A and 8B may be satisfactorily used with an apparatusoperable to deliver fluid to bone marrow in accordance with teachings ofthe present disclosure.

One of the features of such ball detent mechanisms and collet latchmechanisms includes maintaining positive engagement between anassociated plunger operating and cartridge drive mechanism and anattached cartridge assembly until after an associated plunger assemblyhas moved from a first position to a second position. Such movement mayresult in fluids contained in the cartridge assembly being injected at atarget site before disengagement of the cartridge assembly from theplunger operating and cartridge drive mechanism.

Plunger operating and cartridge drive mechanism 50 a such as shown inFIGS. 4A and 4B may include retractable sleeve 158 which functionssimilar to previously described retractable sleeve 58. Retractablesleeve 158 may include groove or recess 170 formed on the insidediameter of retractable sleeve 158. Balls 172 cooperate with driveconnector 150 to maintain positive engagement between cartridge assembly132 a and first end 54 a of drive housing 54 until after fluid has beeninjected from cartridge assembly 132 a.

As an associated drive apparatus inserts bone penetrator 160 to adesired depth at a target site, retractable sleeve 158 will move to itssecond position which allows balls 172 to move radially outward intorecess 170. See FIG. 4B. Movement of balls 172 into recess 170 may allowdisengagement of drive connector 150 from first end 54 a of drivehousing 54. Portions of plunger shaft 142 a may slide out of cavity 94in plunger operating assembly 82. See FIG. 4B. After plunger operatingand cartridge drive mechanism 50 a has inserted bone penetrator 160 at atarget site and plunger shaft 142 a has moved piston 144 from its firstposition to its second position proximate inside diameter portion 134 a,the associated drive apparatus may be disengaged from cartridge assembly132 a. End 145 of plunger shaft 142 a may also be disengaged from piston144 a.

In one embodiment steps such as outlined in FIG. 5 may be followed toemploy apparatus 20 in delivering medication or fluid to bone marrow ata target site. Method 500 may begin with first step 502 which includesmanually compressing plunger barrel 82 and plunger barrel spring 52.Plunger barrel 82 may be releasably engaged by pawl latch assembly 110when plunger barrel spring 52 has been compressed. Step 504 may includeinserting or loading cartridge assembly 130 or 130 a into retractablesleeve 58 and releasably engaging respective cartridge assembly 130 or130 a with an associated plunger operating and cartridge drivemechanism. In one embodiment, cartridge assembly 130 or 130 a may engagedrive housing 54 by a magnetic mechanism such as one or more magneticdiscs 138.

Once cartridge assembly 130 or 130 a is engaged with drive housing 54and plunger operating assembly 82 is in its compressed position,apparatus 20 may be considered “armed” and ready to “fire” an associatedbone penetrator into a target site such as a bone overlying bone marrow.Alternative target sites may include other body tissues or bodycavities. Use of apparatus 20 to deliver medication or fluid may beapplied to any desirable sites in the body.

After preparing a selected target site, for example a humeral head or aproximal tibia, apparatus 20 may be seated with first end 58 a ofretractable sleeve 58 disposed against skin overlying a bone and bonemarrow at the target site for insertion of bone penetrating needle 160.Switch or trigger 32 may be activated to begin drilling into the boneand adjacent target bone marrow. See FIGS. 1C and 1D. Bone penetratingneedle 160 may first penetrate the skin, followed by adjacent softtissue, outer bone cortex and enter bone marrow at the target site. Asfirst end 58 a pushes against tissue overlying a target bone marrow,retractable sleeve 58 will contact pawl latch assembly 110 to releaseplunger operating assembly 82. As first spring decompresses, plungeroperating assembly 82 moves plunger shaft 142 into reservoir 132. Asplunger shaft 142 is forced into reservoir 132, fluid or any othersubstance present within reservoir 132 is forced into the target bonemarrow or intraosseous space of a bone.

After medication or fluid delivery, apparatus 20 may be disengaged fromcartridge assembly 130. Reservoir 132 may then be detached from hub 300.Bone marrow may then be accessed through a connector attached withsecond end 302 of hub 300. See FIG. 1E. These steps describe only oneembodiment of an apparatus operable to administer fluid such as a drugor medication to a target site. Other mechanisms may or may not includeone or more of these steps.

Apparatus 220 as shown in FIG. 6 represents another embodiment operableto provide access to bone marrow or any other target site. Apparatus 220may have several positions including plunger operating and cartridgedrive mechanism 250 in an uncocked and unloaded position (not expresslyshown), a cocked and unloaded position (not expressly shown), a cockedand loaded position such as shown in FIG. 6, and a discharge positionafter fluid has been injected from cartridge assembly 130 a at a targetsite (not expressly shown).

Apparatus 220, as shown in FIG. 6, may include driver 221 with housing222 and a drive assembly (not expressly shown) disposed therein. Thedrive assembly may include a motor, gearbox or gear head, and driveshaft 238 extending from housing 222. Driver 221 may sometimes bereferred to as “powered” driver. Plunger operating and cartridge drivemechanism 250 may or may not be releasably engaged with driver 221.Plunger operating and cartridge drive mechanism 250 will typically be inan uncocked and unloaded position while engaging drive shaft 238 ofdriver 221 therewith.

Housing 222 may include handle 224 which has been sized and contoured tofit the hand of an operator (not expressly shown). Handle 224 mayinclude on/off switch or trigger 232. Drive shaft 238 may extend fromfirst end 227 of housing 222. Second end 228 of housing 222 may besealed or closed to protect various components such as a motor, gearboxor gear head and a power source that may be disposed within housing 222.

Examples of power drivers satisfactory for use with a plunger operatingand cartridge drive assembly incorporating teachings of the presentdisclosure are shown in U.S. Pat. No. 6,183,442 entitled “TissuePenetrating Device and Methods of Using Same” and U.S. Pat. No.5,554,154 entitled “Intra-Osseous Needle Drill.” Power drivers which mayalso be satisfactorily used with a plunger assembly incorporatingteachings of the present disclosure are shown in U.S. patent applicationSer. No. 10/449,530 entitled “Apparatus and Method to Provide EmergencyAccess to Bone Marrow” filed May 30, 2003 and U.S. patent applicationSer. No. 10/449,476 entitled “Apparatus and Method to Access BoneMarrow” filed May 30, 2003. Manual drivers (not expressly shown) mayalso be satisfactorily used with cartridge drive mechanisms and/orplunger operating assemblies incorporating teachings of the presentdisclosure to provide access to bone marrow or other target sites in apatient's body.

Plunger operating and cartridge drive mechanism 250 may include firstspring 251 and second spring. First spring 251 may sometimes be referredto as “plunger spring” 251. Second spring 252 may sometimes be referredto as “retractable sleeve spring” 252. One or more additional springsmay also be disposed within plunger operating and cartridge drivemechanism 250 depending upon mechanisms used to releasably retain acartridge assembly within plunger operating and cartridge drivemechanism 250 and/or allow plunger operating assembly 280 to move from afirst, cocked position to a second, uncocked position.

Plunger operating assembly 280 may be disposed within longitudinal bore256 of plunger operating and drive mechanism 250 adjacent to second end254 b. Plunger operating assembly 280 may include plunger barrel 282.Plunger barrel 282 may include chamber or cavity 292 which is sized toreceive portions of a plunger assembly therein. Plunger operatingassembly 280 may be moved from an uncocked position (not expresslyshown) to a cocked position such as shown in FIG. 6. A cartridgeassembly and bone penetrating needle incorporating teachings of thepresent disclosure may be inserted into retractable sleeve 258 andreleasably engaged with an associated drive connector. Drive connectors150, 150 a, 150 b or any other drive connector incorporating teachingsof the present disclosure may be used.

First end or distal end 258 a of retractable sleeve 258 may then beplaced adjacent to a selected target site. Switch 232 may be depressedto activate driver 221 to rotate drive shaft 238 and insert bonepenetrating needle 160 to a desired depth at the target site. As bonepenetrating needle 160 is inserted into the target site, retractablesleeve 258 will move longitudinally from a first, extended position to asecond, retracted position which results in release of plunger operatingassembly 280 from its first, cocked position and allows first spring orplunger spring 251 to force plunger assembly 140 a to move from itsfirst position to its second position which results in the injection offluids contained within reservoir 132 a into bone marrow at the selectedtarget site. After plunger assembly 140 a has completed injection of thefluid, various release mechanisms such as shown in FIGS. 4A, 4B, 7A, 7B,8A and 8B may be satisfactorily used to disengage cartridge assembly 130a from plunger operating and cartridge drive mechanism 250.

Plunger operating and cartridge drive mechanism 250 may also includedrive housing 254 defined in part by first end 254 a and second end 254b. Drive housing 254 may have a generally hollow cylindricalconfiguration defined in part by longitudinal bore 256 extending fromfirst end 254 a towards second end 254 b. Retractable sleeve 258 may beslidably disposed within longitudinal bore 256 and extend from first end254 a. Retractable sleeve 258 may also include first end or distal end258 a and second end or proximal end 258 b. The outside diameter ofretractable sleeve 258 and the inside diameter of longitudinal bore 256are preferably selected to allow longitudinal sliding movement ofretractable sleeve 258 from its first, extended position as shown inFIG. 6 to a second, retracted position (not expressly shown).

Second end 254 b of drive housing 254 may be generally closed except foropening 262 which is preferably sized to receive drive shaft 23S.Rotation of drive shaft 23S may be transmitted through portions of drivehousing 250 adjacent to opening 256. Drive housing 254 may be used totransmit rotational forces or drilling forces from drive shaft 23S to acartridge assembly releasably engaged with plunger operating andcartridge drive mechanism 250.

FIGS. 7A and 7B show portions of plunger operating and cartridge drivemechanism 50 b with cartridge assembly 130 a releasably attachedthereto. Release mechanism 180 may be generally described as a colletlatch assembly having a plurality of collet fingers 182 with respectivecollet heads 184 disposed on the end of each collet finger 182. Colletlatch assembly 180 may be satisfactorily used to releasably engage driveconnector 150 a of cartridge assembly 130 a proximate first end 54 a ofdrive housing 54 b.

Plunger barrel 82 a may include recess or groove 188 formed on theexterior thereof. As an associated plunger barrel 82 a is shifted from acocked position to a released position, groove 188 will be aligned withsecond end 186 of collet fingers 182. The dimensions of groove 188 arepreferably selected to allow second end 186 of each collet finger 182 tobe received therein. An associated retractable sleeve (not expresslyshown) may include an enlarged inside diameter portion whichaccommodates radial expansion of collet fingers 182 and associatedcollet heads 184 to release their engagement with drive connector 150 a.As a result the associated drive apparatus may be removed from cartridgeassembly 130 a.

FIGS. 8A and 8B show portions of plunger operating and cartridge drivemechanism 50 c with cartridge assembly 130 a releasably attachedthereto. Release mechanism 180 a may be generally described as a colletlatch assembly having a plurality of collet fingers 182 a withrespective collet heads 184 a disposed on the end of each collet finger182 a. Collet latch assembly 180 a may be satisfactorily used toreleasably engage drive connector 150 a of cartridge assembly 130 aproximate first end 54 a of drive housing 54 c.

Plunger shaft or plunger rod 142 b may include recess or groove 176formed on the exterior thereof. As an associated plunger barrel (notexpressly shown) moves from a cocked position to a released position,recess or groove 176 will be aligned with balls 172 a and second end 1S6a of each collet finger 182 a. The dimensions of recess 176 arepreferably selected to allow balls 172 a to be received therein. Anassociated retractable sleeve (not expressly shown) may include anenlarged inside diameter portion which accommodates radial expansion ofcollet fingers 182 a and associated collet heads 184 a to release theirengagement with drive connector 150 a. As a result, the associated driveapparatus may be removed from cartridge assembly 130 a.

Apparatus 20 or 220 may be used to access the bone marrow of any bone inthe body including but not limited to the tibia, humeral head, orsternum. Apparatus 20 or 220 may be used to access the femur, radius,ulna, iliac crest and medial malleolus or any other target site in abody including non-bony targets. Apparatus 20 or 220 may be used toaccess the bones and bone marrow of adults, children and any animalspecies. Apparatus 20 or 200 may also be used to access other tissues orbody cavities.

Apparatus 20 and 220 may be used to administer a unit dose of medicationto bone marrow or other target sites in any form suitable for delivery.Such drugs include, but are not limited to medications for resuscitationduring the treatment of cardiac arrest, antibiotics, poison antidotes,nerve gas antidotes and radio protectants to protect the body againstradiation exposure. Apparatus 20 or 220 may be used to administer anysuitable fluids or other substances suitable for injection into bonemarrow or other sites in the body. Such fluids may include, but are notlimited to, normal saline, lactated Ringer's solution, blood, plasma,albumin or any other bio-compatible fluid.

Apparatus 20 and 220 formed in accordance with teachings of the presentdisclosure may have ergonomic designs that allow insertion pressure orforces, such as rotational, drilling, impact, longitudinal, and/ormanual forces, to be applied with relative ease and at the same timepermit insertion of a bone penetrator extending from an associatedcartridge assembly. Handle 22 and 222 may be aligned with ananatomically neutral position of an operator's hand and wrist as apowered driver rotates a releasably engaged cartridge assembly with abone penetrator extending therefrom. This alignment may allow betteraxial orientation of apparatus 20 and 220 as an associated bonepenetrator is inserted into bone marrow or other target site with lesschance of excessive movement and/or misalignment of the bone penetratorwhich might result in undesired widening and/or elongation of anassociated insertion hole.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alternations can be made herein without departing from the spiritand scope of the disclosure as defined by the following claims.

What is claimed is:
 1. An apparatus for delivering a quantity of fluidto bone marrow comprising: a drive housing comprising a first portionconfigured to engage a driver assembly and a second portion configuredto engage a cartridge assembly, the drive housing configured to receivea rotational force from the driver assembly and to transmit therotational force to the cartridge assembly, the cartridge assemblycomprising a fluid reservoir and a plunger assembly slidably disposed inthe fluid reservoir, the cartridge assembly engaged with a bonepenetrating needle and configured to rotate to insert the bonepenetrating needle into the bone marrow; a plunger operating assemblyconfigured to receive a portion of the plunger assembly of the cartridgeassembly; a retractable sleeve configured to displace longitudinallyrelative to the drive housing and the plunger operating assembly, theretractable sleeve configured to move from a first position to a secondposition; a first spring configured to bias the retractable sleeve inthe first position; a second spring configured to move the plungeroperating assembly such that the plunger operating assembly moves theplunger assembly of the cartridge assembly to deliver the quantity offluid to the bone marrow; a first release mechanism configured torelease the second spring to move the plunger operating assembly; and asecond release mechanism configured to release the engagement betweenthe second portion of the drive housing and the cartridge assembly whenthe quantity of fluid is delivered to the bone marrow, wherein the firstrelease mechanism releases the second spring to move the plungeroperating assembly when the cartridge assembly is rotated to insert thebone penetrating needle into the bone marrow and the retractable sleeveis moved to its second position.
 2. The apparatus of claim 1, where thefirst release mechanism comprises a pawl latch, the pawl latchconfigured to move from a first position to a second position thatreleases the second spring to move the plunger operating assembly,wherein the retractable sleeve comprises a ramp formed on an innersurface of the retractable sleeve, the ramp configured to move the pawllatch from its first position to its second position when the cartridgeassembly is rotated to insert the bone penetrating needle into the bonemarrow and the retractable sleeve is moved to its second position. 3.The apparatus of claim 2, further comprising a third spring configuredto bias the pawl latch in its first position.
 4. The apparatus of claim1, wherein the second release mechanism comprises one or more ballsconfigured to displace radially between a first position and a secondposition, the one or more balls configured to maintain the engagementbetween the second portion of the drive housing and the cartridgeassembly when the one or more balls are in the first position, the oneor more balls configured to release the engagement between the secondportion of the drive housing and the cartridge assembly when the one ormore balls are in the second position.
 5. The apparatus of claim 4,wherein the retractable sleeve comprises one or more recesses formed onan inner surface of the retractable sleeve, each recess configured toreceive a ball of the one or more balls to allow the ball to displaceradially from the first position to the second position.
 6. Theapparatus of claim 4, wherein the second release mechanism furthercomprises one or more latch components configured to displace from afirst position and a second position, wherein the one or more latchcomponents cooperate with the one or more balls to maintain theengagement between the second portion of the drive housing and thecartridge assembly when the one or more latch components and the one ormore balls are in their first positions, wherein the one or more latchcomponents cooperate with the one or more balls to release theengagement between the second portion of the drive housing and thecartridge assembly when the one or more latch components and the one ormore balls are in their second positions.
 7. The apparatus of claim 6,wherein the plunger assembly of the cartridge assembly comprises one ormore recesses formed on an outer surface of the plunger assembly, eachrecess configured to receive a ball of the one or more balls to allowthe ball to displace radially from the first position to the secondposition.
 8. The apparatus of claim 1, wherein the driver assemblycomprises a motor and a drive shaft coupled to and extending from themotor, wherein the first portion of the drive housing comprising anopening configured to receive a portion of the drive shaft.
 9. Anapparatus for delivering a quantity of fluid to bone marrow comprising:a housing; a motor disposed in the housing; a drive shaft coupled to andextending from the motor; a drive housing comprising a first portionconfigured to engage the drive shaft and a second portion configured toengage a cartridge assembly, the drive housing configured to receive arotational force from the drive shaft and to transmit the rotationalforce to the cartridge assembly, the cartridge assembly comprising afluid reservoir and a plunger assembly slidably disposed in the fluidreservoir, the cartridge assembly engaged with a bone penetrating needleand configured to rotate to insert the bone penetrating needle into thebone marrow; a plunger operating assembly configured to receive aportion of the plunger assembly of the cartridge assembly; a retractablesleeve configured to displace longitudinally relative to the drivehousing and the plunger operating assembly, the retractable sleeveconfigured to move from a first position to a second position; a firstspring configured to bias the retractable sleeve in the first position;a second spring configured to move the plunger operating assembly suchthat the plunger operating assembly moves the plunger assembly of thecartridge assembly to deliver the quantity of fluid to the bone marrow;a first release mechanism configured to release the second spring tomove the plunger operating assembly; and a second release mechanismconfigured to release the engagement between the second portion of thedrive housing and the cartridge assembly when the quantity of fluid isdelivered to the bone marrow, wherein the first release mechanismreleases the second spring to move the plunger operating assembly whenthe cartridge assembly is rotated to insert the bone penetrating needleinto the bone marrow and the retractable sleeve is moved to its secondposition.
 10. The apparatus of claim 9, wherein the drive housing, thefirst spring, and the second spring are disposed in portions of thehousing, wherein a portion of the retractable sleeve extends from anopening in the housing.
 11. The apparatus of claim 10, wherein thehousing comprises a handle, wherein the handle comprises a trigger,wherein the trigger is configured to activate the motor to rotate thedrive shaft.
 12. The apparatus of claim 9, where the first releasemechanism comprises a pawl latch, the pawl latch configured to move froma first position to a second position that releases the second spring tomove the plunger operating assembly, wherein the retractable sleevecomprises a ramp formed on an inner surface of the retractable sleeve,the ramp configured to move the pawl latch from its first position toits second position when the cartridge assembly is rotated to insert thebone penetrating needle into the bone marrow and the retractable sleeveis moved to its second position.
 13. The apparatus of claim 12, furthercomprising a third spring configured to bias the pawl latch in its firstposition.
 14. The apparatus of claim 12, wherein the retractable sleevecomprises a reduced diameter portion and an enlarged diameter portionwith a shoulder portion formed between the reduced diameter portion andthe enlarged diameter portion, wherein the ramp is formed on an innersurface of the enlarged diameter portion proximate to the shoulderportion.
 15. The apparatus of claim 9, wherein the second releasemechanism comprises one or more balls configured to displace radiallybetween a first position and a second position, the one or more ballsconfigured to maintain the engagement between the second portion of thedrive housing and the cartridge assembly when the one or more balls arein the first position, the one or more balls configured to release theengagement between the second portion of the drive housing and thecartridge assembly when the one or more balls are in the secondposition.
 16. The apparatus of claim 15, wherein the retractable sleevecomprises one or more recesses formed on an inner surface of theretractable sleeve, each recess configured to receive a ball of the oneor more balls to allow the ball to displace radially from the firstposition to the second position.
 17. The apparatus of claim 9, whereinthe portion of the retractable sleeve that extends from the opening inthe housing comprises a window.
 18. The apparatus of claim 9, wherein atleast the portion of the retractable sleeve that extends from theopening in the housing is formed of a transparent material.
 19. Anapparatus for delivering a quantity of fluid to bone marrow comprising:a drive housing comprising a first portion configured to engage a driverassembly and a second portion configured to engage a cartridge assembly,the drive housing configured to receive a rotational force from thedriver assembly and to transmit the rotational force to the cartridgeassembly, the cartridge assembly comprising a fluid reservoir and aplunger assembly slidably disposed in the fluid reservoir, the cartridgeassembly engaged with a bone penetrating needle and configured to rotateto insert the bone penetrating needle into the bone marrow; a plungeroperating assembly configured to receive a portion of the plungerassembly of the cartridge assembly, the plunger operating assemblyfurther configured to move when the cartridge assembly is rotated toinsert the bone penetrating needle into the bone marrow; a first releasemechanism configured to permit the plunger operating assembly to movefrom a retracted position to a released position; a second releasemechanism configured to release the engagement between the secondportion of the drive housing and the cartridge assembly when thequantity of fluid is delivered to the bone marrow; and a spring loadedretractable sleeve configured to displace longitudinally relative to thedrive housing and the plunger operating assembly, the retractable sleeveconfigured to move from an extended position to a retracted position;wherein the plunger operating assembly is configured to move the plungerassembly of the cartridge assembly to deliver the quantity of fluid tothe bone marrow when the plunger operating assembly is moved to thereleased position and the retractable sleeve is moved to the retractedposition.
 20. The apparatus of claim 19, wherein the second releasemechanism is further configured to maintain a positive engagementbetween the drive housing and the cartridge assembly until after theplunger assembly of the cartridge assembly has moved from a firstposition to a second position such that the quantity of fluid containedin the cartridge assembly is injected at a target site beforedisengagement of the cartridge assembly from the drive housing.